Mobile Monitor Cart System MMCS

Primary DI
19120075320105
Brand
Mobile Monitor Cart System MMCS
Company
medPhoton GmbH
Model
1
Catalog number
A0093
Device description
"Mobile Monitor Cart System ""MMCS"":The Mobile Monitor Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Mobile Monitor Cart System can be used to move medical equipment (e.g. the IRm control unit) within the building or to position it in the room.If the system is used in conjunction with the IRm operating unit, the mobile monitor cart system expands the display and control options of the mobile X-ray imaging system ""ImagingRing m"" or ""Loop-X®"" (abbreviated Rm) of medPhoton GmbH.The mobile monitor cart system is listed and released as an accessory and included in the technical documentation and 510(k) premarket submissions for the ImagingRing m. Therefore it is also registered under the same listing number and product code."
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203281000
K234067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203281000Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH2020-12-22OWB
K234067000ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)Medphoton GmbH2025-03-28OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19120075320105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1912007532010519120075320105

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300376801
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120075320020ImagingRing r12026-04-21
19120075320136Remote Control Charging Cart RCCS1A010522025-06-10
19120075320112ImagingRing m2P04-12025-05-28
19120075320129Loop-X2P04-22025-05-28
19120075320013ImagingRing1.12018-02-09
19120075320037ImagingRing1.22018-10-25
19120075320068ImagingRing m12021-03-22
19120075320075Loop-X1P04-22021-03-22

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